This trial is active, not recruiting.

Conditions atherosclerosis, cardiovascular diseases, coronary artery disease
Sponsor Hiroshima University
Start date October 2009
End date December 2012
Trial size 3015 participants
Trial identifier NCT00991835, PREDICT2009


Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Major cardiac events (Cardiac death and acute coronary syndrome)
time frame: 2 years after the CT-scan
All-cause death
time frame: 2 years after the CT-scan

Secondary Outcomes

All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations)
time frame: 2 years after CT-scan
All cardiovascular events (Death, acute coronary syndrome, heart failure, cerebral disease, peripheral artery disease, aortic disease, and renal failure)
time frame: 2 years after the CT-scan

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - patients with known or suspected coronary artery disease. Exclusion Criteria: - irregular heart beat, - known allergy towards the contrast agent, - renal dysfunction, - uncontrolled heart failure, - previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition, - impossible breath-hold, OR - end-stage cancer.

Additional Information

Official title Prospective Multicenter Study to Investigate the Relationship Between the Characteristics of Coronary Artery Plaques and Cardiovascular Events Using Multidetector Computed Tomography Coronary Angiography
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Hiroshima University.